Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

7 mm Extended Length Endoscope

K-Number: K191930 · 2020-04-15

ApplicantMaquet Cardiovascular, LLC
Decision Date2020-04-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

7 mm Extended Length Endoscope is a medical device manufactured by Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2020-04-15 under approval number K191930. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7 mm Extended Length Endoscope?

7 mm Extended Length Endoscope is a medical device that received FDA 510(k) clearance on 2020-04-15. It is manufactured by Maquet Cardiovascular, LLC. The 510(k) number is K191930.

When was 7 mm Extended Length Endoscope approved by the FDA?

7 mm Extended Length Endoscope received FDA 510(k) clearance on 2020-04-15, under approval number K191930.

What company makes 7 mm Extended Length Endoscope?

7 mm Extended Length Endoscope is manufactured by Maquet Cardiovascular, LLC.

What is the FDA product code for 7 mm Extended Length Endoscope?

The FDA product code for 7 mm Extended Length Endoscope is GCJ.

Related Clinical Trials

NCT07539792 Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study RECRUITING NCT07425015 Ambulatory Long Length URodynamics Evaluation RECRUITING

Other Devices by Maquet Cardiovascular, LLC

K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting System K153523FUSION Vascular Graft K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) K243918Vasoview Hemopro 3 Power Supply

View all 8 devices →

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑